Journal of Vascular Surgery
Volume 50, Issue 2 , Pages 349-354 , August 2009

Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials

Presented at the Thirty-sixth Annual Symposium of the Society for Clinical Vascular Surgery, Las Vegas, Nev, Mar 5-8, 2008.

  • Andrew W. Hoel, MD

      Affiliations

    • Division of Vascular Surgery, Brigham & Women's Hospital, Boston, Mass
  • ,
  • Ahmed Kayssi, MSc

      Affiliations

    • Division of Vascular Surgery, Brigham & Women's Hospital, Boston, Mass
  • ,
  • Soma Brahmanandam, MD, MPH

      Affiliations

    • Department of Surgery, University of Massachusetts Medical Center, Worchester, Mass
  • ,
  • Michael Belkin, MD

      Affiliations

    • Division of Vascular Surgery, Brigham & Women's Hospital, Boston, Mass
  • ,
  • Michael S. Conte, MD

      Affiliations

    • Division of Vascular Surgery, University of California San Francisco Medical Center, San Francisco, Calif
  • ,
  • Louis L. Nguyen, MD, MBA, MPH

      Affiliations

    • Division of Vascular Surgery, Brigham & Women's Hospital, Boston, Mass
    • Center for Surgery & Public Health, Brigham & Women's Hospital, Boston, Mass
    • Corresponding Author InformationCorrespondence: Louis L. Nguyen, MD, MBA, MPH, Division of Vascular & Endovascular Surgery and the Center for Surgery & Public Health, Brigham & Women's Hospital, 75 Francis St, Boston, MA 02115

Received 18 October 2008 ,Accepted 7 January 2009.

References 

  1. Kullo IJ, Bailey KR, Kardia SL, Mosley TH, Boerwinkle E, Turner ST. Ethnic differences in peripheral arterial disease in the NHLBI Genetic Epidemiology Network of Arteriopathy (GENOA) study. Vasc Med. 2003;8:237–242
  2. Sosin MD, Bhatia GS, Lip GY, Davis RC. Drug development and the importance of ethnicity: lessons from heart failure management and implications for hypertension. Curr Pharm Des. 2004;10:3569–3577
  3. Chew DK, Nguyen LL, Owens CD, Conte MS, Whittemore AD, Gravereaux EC, et al. Comparative analysis of autogenous infrainguinal bypass grafts in African Americans and Caucasians: the association of race with graft function and limb salvage. J Vasc Surg. 2005;42:695–701
  4. Morrissey NJ, Giacovelli J, Egorova N, Gelijns A, Moskowitz A, McKinsey J, et al. Disparities in the treatment and outcomes of vascular disease in Hispanic patients. J Vasc Surg. 2007;46:971–978
  5. Criqui MH, Vargas V, Denenberg JO, Ho E, Allison M, Langer RD, et al. Ethnicity and peripheral arterial disease: the San Diego Population Study. Circulation. 2005;112:2703–2707
  6. Allison MA, Ho E, Denenberg JO, Langer RD, Newman AB, Fabsitz RR, et al. Ethnic-specific prevalence of peripheral arterial disease in the United States. Am J Prev Med. 2007;32:328–333
  7. Feinglass J, Rucker-Whitaker C, Lindquist L, McCarthy WJ, Pearce WH. Racial differences in primary and repeat lower extremity amputation: results from a multihospital study. J Vasc Surg. 2005;41:823–829
  8. Trivedi AN, Sequist TD, Ayanian JZ. Impact of hospital volume on racial disparities in cardiovascular procedure mortality. J Am Coll Cardiol. 2006;47:417–424
  9. Acosta S, Ogren M, Bengtsson H, Bergqvist D, Lindblad B, Zdanowski Z. Increasing incidence of ruptured abdominal aortic aneurysm: a population-based study. J Vasc Surg. 2006;44:237–243
  10. Dillavou ED, Muluk SC, Makaroun MS. A decade of change in abdominal aortic aneurysm repair in the United States: Have we improved outcomes equally between men and women?. J Vasc Surg. 2006;43:230–238
  11. Nguyen LL, Hevelone N, Rogers SO, Bandyk DF, Clowes AW, Moneta GL, et al. Disparity in outcomes of surgical revascularization for limb salvage. race and gender are synergistic determinants of vein graft failure and limb loss. Circulation. 2009;119:123–130
  12. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162:1682–1688
  13. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291:2720–2726
  14. Varmus H. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register. 1994;59:14508–14513
  15. Freedman LS, Simon R, Foulkes MA, Friedman L, Geller NL, Gordon DJ, et al. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993--the perspective of NIH clinical trialists. Control Clin Trials. 1995;16:277–285discussion 286-9, 293-309
  16. Corbie-Smith G, St George DM, Moody-Ayers S, Ransohoff DF. Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities. J Clin Epidemiol. 2003;56:416–420
  17. Geller SE, Adams MG, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials. J Womens Health (Larchmt). 2006;15:1123–1131
  18. Oddone EZ, Olsen MK, Lindquist JH, Orr M, Horner R, Reda D, et al. Enrollment in clinical trials according to patients race: experience from the VA Cooperative Studies Program (1975-2000). Control Clin Trials. 2004;25:378–387
  19. Branson RD, Davis K, Butler KL. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg. 2007;193:32–39
  20. Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, et al. Are racial and ethnic minorities less willing to participate in health research?. PLoS Med. 2006;3:e19
  21. Katz RV, Kegeles SS, Kressin NR, Green BL, Wang MQ, James SA, et al. The Tuskegee Legacy Project: Willingness of minorities to participate in biomedical research. J Health Care Poor Underserved. 2006;17:698–715
  22. Horton R. Trials of women. Lancet. 1994;343:745–746
  23. Uhl K, Parekh A, Kweder S. Females in clinical studies: where are we going?. Clin Pharmacol Ther. 2007;81:600–602
  24. Brancati FL, Whittle JC, Whelton PK, Seidler AJ, Klag MJ. The excess incidence of diabetic end-stage renal disease among blacks (A population-based study of potential explanatory factors). JAMA. 1992;268:3079–3084
  25. Whittle JC, Whelton PK, Seidler AJ, Klag MJ. Does racial variation in risk factors explain black-white differences in the incidence of hypertensive end-stage renal disease?. Arch Intern Med. 1991;151:1359–1364

 This work was supported by a National Institutes of Health (NIH) K23 Research Career Development Award (HL084386) to Dr Nguyen.

 Competition of interest: none.

 Additional material for this article may be found online at www.jvascsurg.org.

PII: S0741-5214(09)00018-4

doi: 10.1016/j.jvs.2009.01.012

Journal of Vascular Surgery
Volume 50, Issue 2 , Pages 349-354 , August 2009